CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH- benzocaine and dextromethorphan hydrobromide lozenge

Cepacol by

Drug Labeling and Warnings

Cepacol by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each lozenge)	Purposes
Benzocaine 7.5 mg	Oral pain reliever
Dextromethorphan HBr 5 mg	Cough suppressant

Uses

For the temporary relief of occasional

• cough due to minor throat and bronchial irritation as may occur with the common cold
• sore throat
• sore mouth
• minor irritation
• pain
• pain associated with canker sores

Warnings

Methemoglobinemia warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Do not use

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• for teething
• in children under 6 years of age

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor or dentist if

• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
• swelling develops
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed recommended dosage.

Directions

• adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist
• children 6 to under 12 years of age: take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist
• children under 6 years of age: do not use

Other information

• store at 20-25°C (68-77°F)
• protect contents from humidity

Inactive ingredients

FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, purified water, sucralose

Questions?

1-866-682-4639
You may also report side effects to this phone number.

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Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

NDC: 63824-744-16
READ ALL WARNINGS

Cēpacol®
EXTRA STRENGTH

#1
DOCTOR
RECOMMENDED†

SORE THROAT & COUGH
Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant

• Relieves Sore Throat Pain
• Quiets Cough    Fast Acting
• Maximum Numbing*

16 Lozenges mixed berry
*based on amount of benzocaine per adult dose

INGREDIENTS AND APPEARANCE

CEPACOL   EXTRA STRENGTH SORE THROAT AND COUGH
benzocaine and dextromethorphan hydrobromide lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-744
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Red No. 40 (UNII: WZB9127XOA)
isomalt (UNII: S870P55O2W)
maltitol (UNII: D65DG142WK)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium bicarbonate (UNII: 8MDF5V39QO)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	18mm
Flavor	BERRY	Imprint Code	S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-744-16	2 in 1 CARTON	05/05/2014
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63824-744-94	1 in 1 CARTON	05/05/2014
2		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 63824-744-36	3 in 1 CARTON	05/01/2019
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	05/05/2014

Labeler - RB Health (US) LLC (081049410)